Source: GlobalData
Alzheon’s valiltramiprosate poised to meet high unmet need for MCI APOE4 homozygotes, says GlobalData
Posted in Pharma
At the recently held AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases (PD), Alzheon presented promising Phase III APOLLOE4 trial results for its drug ALZ-801 (valiltramiprosate) in treating mild cognitive impairment (MCI) in APOE4 homozygous patients, highlighting its potential to meet the high unmet need for a safe, effective treatment in this population, says GlobalData, leading data and analytics company.
Pippa Salter, Managing Neurology Analyst at GlobalData, comments: “Given the APOLLOE4 results, it remains to be seen whether Alzheon will pursue regulatory approval for early AD or if it will pivot to just the MCI patient population. There is also the potential for expansion as Alzheon plans to evaluate valiltramiprosate in additional patient populations, with prevention in APOE4 homozygotes a promising option since the results of the APOLLOE4 trial showed that valiltramiprosate was more effective the earlier in the disease it was administered.”
The results presented in MCI patients are particularly promising as Alzheon is targeting a subset of AD patients where there is high unmet need. AD patients who are APOE4 homozygous typically have more rapid clinical decline, and a higher risk of developing amyloid-related imaging abnormalities (ARIAs).
Salter continues: “The current disease-modifying therapies (DMTs) approved for the treatment of early AD—Eisai/Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab)—are associated with risk of ARIA. As such, their use is limited in APOE4 homozygotes, with some regulators only approving these drugs for patients with one copy or no copy of the APOE4 gene, such as the EMA’s approval of Leqembi. In contrast to the mAbs, valiltramiprosate resulted in no increased risk of ARIA when compared with placebo. Thus, Alzheon will be able to position valiltramiprosate as a safe and effective treatment option for a patient population with high unmet need.”
GlobalData’s Alzheimer’s Disease in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033 report reveals that valiltramiprosate will generate US sales of approximately $663.3 million in the MCI patient populations in 2033, accounting for 82% of its potential total early AD sales.
Salter concludes: “The fact that valiltramiprosate is orally administered gives it a further competitive advantage over the anti-Aβ mAbs in terms of ease of administration for patients.”